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Prostatic Neoplasms clinical trials

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NCT ID: NCT00928850 Completed - Prostate Cancer Clinical Trials

Modifications to Radical Prostatectomy: Feasibility Study

Start date: June 2009
Phase: N/A
Study type: Interventional

This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing. Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed. All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients. Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.

NCT ID: NCT00928434 Completed - Prostate Cancer Clinical Trials

A Study of Degarelix in Patients With Prostate Cancer

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The purpose is to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) will show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

NCT ID: NCT00928252 Completed - Clinical trials for Hormone Refractory Prostate Cancer

Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.

NCT ID: NCT00928174 Completed - Prostate Cancer Clinical Trials

Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.

NCT ID: NCT00925600 Completed - Prostate Cancer Clinical Trials

A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

Start date: November 2009
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in subjects with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.

NCT ID: NCT00925418 Completed - Prostate Cancer Clinical Trials

Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer

CRYO1
Start date: September 2006
Phase: Phase 3
Study type: Interventional

Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer. Primary objective: Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®. Secondary objectives: Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove

NCT ID: NCT00924469 Completed - Prostate Cancer Clinical Trials

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).

NCT ID: NCT00924313 Completed - Prostate Cancer Clinical Trials

Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer

Start date: September 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positron emission tomography (PET) scans. - An experimental radioactive tracer called 11C-acetate accumulates in prostate tumor cells and may help find prostate cancers more accurately than other imaging methods. Objectives: - To determine the accuracy of prostate tumor imaging using the tracer 11C-acetate. Eligibility: - Patients 18 years of age and older who are undergoing surgery for localized prostate cancer at the National Institutes of Health (NIH) Clinical Center. Design: - Patients have a positron emission tomography (PET scan). For this test, an intravenous (IV) line is placed in the patient's arm and the patient lies on a table inside the donut shaped scanner. (11)C-acetate is injected into the vein through the catheter and images of the lower pelvis and abdomen are obtained over 30 minutes. - Patients have an endorectal coil MRI scan. For this test, a tube is placed in the rectum, just behind the prostate, to increase the amount of signal received by the magnetic resonance (MR) unit. Other coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on the scanning table for about 75 to 90 minutes while images are obtained. During the scan, a contrast agent called gadolinium is injected through an intravenous (IV) line to brighten the images.

NCT ID: NCT00923416 Completed - Prostate Cancer Clinical Trials

Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events

Start date: September 2008
Phase: N/A
Study type: Observational

The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.

NCT ID: NCT00923104 Completed - Breast Cancer Clinical Trials

An Exploratory Evaluation of Biomarkers in Blister Fluid in Healthy Volunteers and Irradiated Skin

Start date: April 23, 2009
Phase:
Study type: Observational

Background: - Blister fluid contains many of the same biomarkers (substances that can be used to determine the effects of certain kinds of treatments) as blood and urine samples, particularly regarding changes in the skin. - The Radiation Oncology Branch and others are conducting research studies that require blood and urine samples from healthy volunteers and from patients with cancer. In addition to these samples, researchers would like to collect the fluid from blisters to examine markers of inflammation in the skin. Objectives: - To compare blood, urine, and blister fluid samples of patients with cancer who are undergoing radiation therapy to that of volunteers without cancer who will not be receiving radiation therapy. - To gather more information about the effects of radiation therapy on the skin and body fluids of individuals. Eligibility: - Patients 18 years of age and older who will be receiving radiation therapy for either breast or prostate cancer. - A separate group of healthy volunteers will also participate in this study. Design: - Physical examination and blood samples to determine eligibility for the study. - Blister induction, conducted before the start of radiation treatment, at completion of radiotherapy (last day of treatment), and at a visit 12 months after the end of radiation treatment. - Blisters will be created through the use of a suction blister device on the hip (for patients with prostate cancer) or on the treated breast or location of removed breast (for patients with breast cancer). - Blisters will take approximately 30 minutes to form, and fluid will be removed with a needle and syringe. - Blood and urine samples will also be collected at this time. - Radiation treatment for breast or prostate cancer will be conducted according to standard procedures, or as directed by a separate research protocol. - Evaluations during the treatment period: - Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. - Blood and urine tests. - Disease evaluation. - Post-treatment evaluations: - Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for physical examination and disease assessment. - Study will end 1 year after the final radiation treatment, upon the collection of the final (third) blister fluid sample.